Spinal Anesthesia Induced Hypotension During Cesarean Section
- Conditions
- Hypotension
- Interventions
- Registration Number
- NCT00846651
- Lead Sponsor
- Milton S. Hershey Medical Center
- Brief Summary
The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections.
- Detailed Description
Many women experience low blood pressure after spinal anesthesia for Cesarean section. This low blood pressure may result in nausea, vomiting dizziness and impairment of uterine blood flow.The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections. In both methods, we will attempt to prevent low blood pressure using phenylephrine infusion that has been shown to be effective in recent research. In addition to receiving phenylephrine one group of patients will receive standard salt solution (Ringer's lactate solution), while the other group will receive a different, intravenous fluid called hydroxyethylstarch.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 82
- American Society of Anesthesiologists (ASA) physical status I and II
- Elective cesarean section
- Weight 50-120 kg, Height 150-180 cm
- Normal singleton pregnancy
- Beyond 36 weeks gestation
- No known fetal abnormalities
- Ages 18-35
- Contraindications to spinal anesthesia
- Multiple gestation, placenta previa, accreta
- Pregnancy induced hypertension or preeclampsia
- Diabetes mellitus, cardiovascular diseases
- Coagulopathy
- Spinal cord abnormalities, spinal surgery, or preexisting neurological dysfunction
- Baseline HR <65
- Failed spinal anesthesia/inadequate sensory block for surgery
- History of abnormal bleeding
- History of adverse reactions to hydroxyethylstarch
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description colloid, then phenylephrine infusion Colloid administration colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. crystalloid, then phenylephrine infusion Crystalloid administration crystalloid administration; The patients received 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min prior to spinal anesthesia for cesarean section. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. colloid, then phenylephrine infusion phenylephrine infusion colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. crystalloid, then phenylephrine infusion phenylephrine infusion crystalloid administration; The patients received 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min prior to spinal anesthesia for cesarean section. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
- Primary Outcome Measures
Name Time Method Incidence of Maternal Hypotension participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
- Secondary Outcome Measures
Name Time Method Incidence of Maternal Bradycardia participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby Fetal Cord Blood pH delivery of the baby Dosage of Phenylephrine Used participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby APGAR Scores Apgar scores were assessed at 1 amd 5 min after delivery of the baby The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10 with higher scores being better than lower scores. The five criteria are summarized using words chosen to form an acronym (Appearance, Pulse, Grimace, Activity, Respiration).
Incidence of Maternal Nausea and Vomiting participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
Trial Locations
- Locations (1)
PennState Hershey Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States